A Study to Evaluate the Change in Disease State and Adverse Events in Adult Participants With Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment, Receiving Subcutaneous Injections of ABBV-154
- Conditions
- Polymyalgia Rheumatica
- Interventions
- Registration Number
- NCT04972968
- Lead Sponsor
- AbbVie
- Brief Summary
Polymyalgia rheumatica (PMR) is an inflammatory disease causing shoulder, hip, and neck pain and stiffness, in adults aged 50 years or older. This study evaluates how safe and effective ABBV-154 is in participants with glucocorticoid-dependent PMR. Adverse events and change in disease activity will be assessed.
ABBV-154 is an investigational drug being evaluated for the treatment of PMR. Participants will be randomized into 1 of 4 treatment groups or arms, each arm receiving a different treatment. There is a 1 in 4 chance that a participant will be assigned to placebo. Around 160 participants, of at least 50 years of age, with PMR will be enrolled in the study at approximately 95 sites worldwide.
The study is compromised of a 52 week double-blind, placebo-controlled period and a follow-up visit 70 days after the last dose of the study drug. All participants will receive a glucocorticoid taper along with the assigned dose of ABBV-154 or placebo, subcutaneously (SC) every other week (eow).
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 181
- Clinical diagnosis of Polymyalgia Rheumatica (PMR) and fulfillment of the 2012 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) provisional classification criteria for PMR.
- Must have had at least 2 episodes of unequivocal PMR flare.
- Must be on a stable dose of prednisone.
- Must be willing to follow the protocol-defined glucocorticoid tapering regimen.
- Have been treated with a prior TNF antagonist.
- Current use of immunomodulators other than prednisone and hydroxychloroquine.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Glucocorticoid Participants will receive placebo SC eow for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper. ABBV-154 Dose B ABBV-154 Participants in this group will receive dose B of ABBV-154 SC eow for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper. ABBV-154 Dose B Glucocorticoid Participants in this group will receive dose B of ABBV-154 SC eow for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper. ABBV-154 Dose A Glucocorticoid Participants in this group will receive dose A of ABBV-154 subcutaneously (SC) every other week (eow) for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper. Placebo Placebo Participants will receive placebo SC eow for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper. ABBV-154 Dose C ABBV-154 Participants in this group will receive dose C of ABBV-154 SC eow for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper. ABBV-154 Dose A ABBV-154 Participants in this group will receive dose A of ABBV-154 subcutaneously (SC) every other week (eow) for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper. ABBV-154 Dose C Glucocorticoid Participants in this group will receive dose C of ABBV-154 SC eow for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.
- Primary Outcome Measures
Name Time Method Time to Flare From first dose of study drug to Week 52 Flare is defined as, presence of clinical signs and symptoms of PMR and requirement to increase the glucocorticoid dose per investigator.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving Flare-Free State Up to Week 24 Percentage of participants achieving flare-free state.
Cumulative Glucocorticoid Dose Week 24 Cumulative glucocorticoid dose.
Change From Baseline in Glucocorticoid Dose Week 24 Change from Baseline in glucocorticoid dose.
Trial Locations
- Locations (117)
Kistarcsai Flor Ferenc Korhaz /ID# 229676
ðŸ‡ðŸ‡ºKistarcsa, Hungary
Kuwana city medical center /ID# 231936
🇯🇵Kuwana-shi, Mie, Japan
Hospital Universitario Marques de Valdecilla /ID# 229297
🇪🇸Santander, Cantabria, Spain
Arthritis and Rheumatism Associates /ID# 232089
🇺🇸Jonesboro, Arkansas, United States
Providence Medical Foundation /ID# 228681
🇺🇸Fullerton, California, United States
Care Access Research, Huntington Beach /ID# 228677
🇺🇸Huntington Beach, California, United States
Purushotham & Akther Kotha MD, Inc /ID# 245391
🇺🇸La Mesa, California, United States
Arthritis & Osteo Medical Ctr /ID# 228680
🇺🇸La Palma, California, United States
Hans Richard Barthel, M.D., Inc /ID# 231902
🇺🇸Santa Barbara, California, United States
Medvin Clinical Research /ID# 228675
🇺🇸Tujunga, California, United States
Inland Rheum & Osteo Med Grp /ID# 228679
🇺🇸Upland, California, United States
Denver Arthritis Clinic /ID# 245736
🇺🇸Denver, Colorado, United States
Delaware Arthritis /ID# 230110
🇺🇸Lewes, Delaware, United States
Arthritis & Rheumatic Disease Specialties /ID# 245448
🇺🇸Aventura, Florida, United States
Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 232238
🇺🇸Boca Raton, Florida, United States
International Medical Research /ID# 228765
🇺🇸Daytona Beach, Florida, United States
Omega Research Debary, LLC /ID# 245450
🇺🇸DeBary, Florida, United States
Lakes Research, LLC /ID# 228757
🇺🇸Miami, Florida, United States
HMD Research LLC /ID# 228767
🇺🇸Orlando, Florida, United States
Springfield Clinic /ID# 228840
🇺🇸Springfield, Illinois, United States
Four Rivers Clinical Research /ID# 228858
🇺🇸Paducah, Kentucky, United States
Rheumatology Consultants - Clinical Research /ID# 232137
🇺🇸Tupelo, Mississippi, United States
Dartmouth-Hitchcock Medical Center /ID# 229557
🇺🇸Lebanon, New Hampshire, United States
Ocean Rheumatology, PA /ID# 232539
🇺🇸Toms River, New Jersey, United States
Hospital for Special Surgery /ID# 228577
🇺🇸New York, New York, United States
St. Lawrence Health System /ID# 229702
🇺🇸Potsdam, New York, United States
University of Rochester Medical Center /ID# 232554
🇺🇸Rochester, New York, United States
Paramount Medical Research Con /ID# 228839
🇺🇸Middleburg Heights, Ohio, United States
Clinical Research Source, Inc. /ID# 231903
🇺🇸Perrysburg, Ohio, United States
Altoona Ctr Clinical Res /ID# 232493
🇺🇸Duncansville, Pennsylvania, United States
Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 228860
🇺🇸Summerville, South Carolina, United States
West Tennessee Research Institute /ID# 228854
🇺🇸Jackson, Tennessee, United States
Rheumatology Care Center PLLC /ID# 232306
🇺🇸Bellaire, Texas, United States
DM Clinical Research - Tomball /ID# 245512
🇺🇸Tomball, Texas, United States
Emeritus Research Sydney /ID# 229166
🇦🇺Botany, New South Wales, Australia
Royal Prince Alfred Hospital /ID# 244888
🇦🇺Camperdown, New South Wales, Australia
BJC Health /ID# 244839
🇦🇺Paramatta, New South Wales, Australia
Tasman Health Care /ID# 230829
🇦🇺Southport, Queensland, Australia
The Queen Elizabeth Hospital /ID# 229049
🇦🇺Woodville South, South Australia, Australia
Emeritus Research /ID# 229270
🇦🇺Camberwell, Victoria, Australia
Austin Health /ID# 229164
🇦🇺Heidelberg, Victoria, Australia
Fiona Stanley Hospital /ID# 229050
🇦🇺Murdoch, Western Australia, Australia
Rheuma-Zentrum Wien-Oberlaa GmbH /ID# 229436
🇦🇹Vienna, Wien, Austria
Rheumatology Research Associates /ID# 230363
🇨🇦Edmonton, Alberta, Canada
The Waterside Clinic /ID# 230364
🇨🇦Barrie, Ontario, Canada
CISSSBSL -Hopital regional de Rimouski /ID# 228394
🇨🇦Rimouski, Quebec, Canada
Centre de Recherche Musculo-Squelettique /ID# 228392
🇨🇦Trois-rivières, Quebec, Canada
CHU de Besancon - Jean Minjoz /ID# 244897
🇫🇷Besancon, Doubs, France
Hopital de la Cavale Blanche /ID# 228348
🇫🇷Brest, Finistere, France
CHU Montpellier - Hôpital Lapeyronie /ID# 228347
🇫🇷Montpellier, Herault, France
Centre Hospitalier du Mans /ID# 229044
🇫🇷Le Mans CEDEX 9, Sarthe, France
CHRU Tours - Hopital Trousseau /ID# 228349
🇫🇷Chambray Les Tours, France
AP-HP - Hopital Cochin /ID# 231800
🇫🇷Paris, France
Medius Klinik Kirchheim /ID# 228660
🇩🇪Kirchheim unter Teck, Baden-Wuerttemberg, Germany
Immanuel Krankenhaus Berlin /ID# 228659
🇩🇪Berlin-buch, Germany
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 228661
🇩🇪Berlin, Germany
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 228658
🇩🇪Hamburg, Germany
Rheumazentrum Ratingen /ID# 245183
🇩🇪Ratingen, Germany
Debreceni Egyetem Klinikai Kozpont /ID# 241674
ðŸ‡ðŸ‡ºDebrecen, Hajdu-Bihar, Hungary
Obudai Egeszsegugyi Centrum Kft. Zalaegerszeg /ID# 229759
ðŸ‡ðŸ‡ºZalaegerszeg, Zala, Hungary
Clinexpert Kft /ID# 229677
ðŸ‡ðŸ‡ºBudapest, Hungary
Obudai Egeszsegugyi Centrum Kft. /ID# 231121
ðŸ‡ðŸ‡ºBudapest, Hungary
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz /ID# 229758
ðŸ‡ðŸ‡ºGyula, Hungary
CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 230065
ðŸ‡ðŸ‡ºSzekesfehervar, Hungary
Csongrad-Csanad Megyei Dr. Bugyi Istvan Korhaz /ID# 229793
ðŸ‡ðŸ‡ºSzentes, Hungary
ASL 3 Genovese - Ospedale la Colletta /ID# 229282
🇮🇹Arenzano, Genova, Italy
A.O.U. Citta della Salute e della Scienza di Torino /ID# 229080
🇮🇹Turin, Torino, Italy
Vital Medical Center Orvosi es Fogaszati Kozpont (Vital Medicina Kft.) /ID# 229674
ðŸ‡ðŸ‡ºVeszprém, Hungary
Azienda Ospedaliero-Universitaria di Modena /ID# 228825
🇮🇹Modena, Italy
Fondazione IRCCS Policlinico /ID# 245274
🇮🇹Pavia, Italy
Azienda Ospedaliero-Universitaria Senese-Ospedale Santa Maria delle Scotte /ID# 245273
🇮🇹Siena, Italy
Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 228815
🇮🇹Udine, Italy
Daido Clinic /ID# 230204
🇯🇵Nagoya-shi, Aichi, Japan
NHO Nagoya Medical Center /ID# 232420
🇯🇵Nagoya-shi, Aichi, Japan
National Hospital Organization Shimoshizu National Hospital /ID# 230500
🇯🇵Yotsukaido-shi, Chiba, Japan
Matsuyama Red Cross Hospital /ID# 230458
🇯🇵Matsuyama-shi, Ehime, Japan
Sanuki Municipal Hospital /ID# 230202
🇯🇵Sanuki-shi, Kagawa, Japan
Kyushu University Beppu Hospital /ID# 232250
🇯🇵Beppu-shi, Oita, Japan
Japanese Red Cross Okayama Hospital /ID# 230857
🇯🇵Okayama-shi, Okayama, Japan
Rinku Hashimoto Rheumatology Orthopaedics /ID# 246532
🇯🇵Izumisano-shi, Osaka, Japan
Tokyo Medical And Dental University Hospital /ID# 232206
🇯🇵Bunkyo-ku, Tokyo, Japan
Osaka Medical and Pharmaceutical University Hospital /ID# 246530
🇯🇵Takatsuki-shi, Osaka, Japan
Toyama Prefectural Central Hospital /ID# 230616
🇯🇵Toyama-shi, Toyama, Japan
Hanyang University Seoul Hospital /ID# 228719
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Kyungpook National University Hospital /ID# 228716
🇰🇷Daegu, Korea, Republic of
ZiekenhuisGroep Twente /ID# 229071
🇳🇱Almelo, Netherlands
Universitair Medisch Centrum Groningen /ID# 227727
🇳🇱Groningen, Netherlands
Medisch Centrum Leeuwarden /ID# 245442
🇳🇱Leeuwarden, Netherlands
Maastricht Universitair Medisch Centrum /ID# 227779
🇳🇱Maastricht, Netherlands
Maasstad Ziekenhuis /ID# 228064
🇳🇱Rotterdam, Netherlands
Optimal Clinical Trials Ltd /ID# 229048
🇳🇿Grafotn, Auckland, New Zealand
Timaru Medical Specialists Ltd /ID# 229098
🇳🇿Timaru, Canterbury, New Zealand
Aotearoa Clinical Trials /ID# 229099
🇳🇿Papatoetoe, Auckland, New Zealand
Waikato Hospital /ID# 229047
🇳🇿Hamilton, Waikato, New Zealand
Wellington Regional Hospital /ID# 229490
🇳🇿Newtown, Wellington, New Zealand
CGM Research Trust /ID# 244893
🇳🇿Christchurch Central, New Zealand
Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o /ID# 228357
🇵🇱Wroclaw, Dolnoslaskie, Poland
Szpital Uniwersytecki nr 2 im. dr. Jana Biziela /ID# 228353
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
Centrum Medyczne Reuma Park /ID# 244813
🇵🇱Warszawa, Mazowieckie, Poland
Nova Reuma Domyslawska I Rusilowicz - Spolka Partnerska Lekarza Reumatologa I Fi /Id# 228466
🇵🇱Bialystok, Podlaskie, Poland
AI Centrum Medyczne Sp. z o.o. sp.k. /ID# 228951
🇵🇱Poznan, Wielkopolskie, Poland
Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 228314
🇵🇱Poznan, Wielkopolskie, Poland
Hospital ClÃnico Universitario de Santiago-CHUS /ID# 244868
🇪🇸Santiago de Compostela, A Coruna, Spain
Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 244866
🇪🇸Sabadell, Barcelona, Spain
Hospital Universitario Canarias /ID# 229451
🇪🇸San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
Hospital Clinic de Barcelona /ID# 229295
🇪🇸Barcelona, Spain
Hospital General Universitario Gregorio Maranon /ID# 229302
🇪🇸Madrid, Spain
Hospital Clinico Universitario San Carlos /ID# 229296
🇪🇸Madrid, Spain
North West Anglia NHS Foundation Trust /ID# 230866
🇬🇧Bretton, Cambridgeshire, United Kingdom
Leicester Royal Infirmary /ID# 231967
🇬🇧Leicester, England, United Kingdom
The Royal Free London NHS Foundation Trust /ID# 231707
🇬🇧London, London, City Of, United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 231966
🇬🇧Norwich, Norfolk, United Kingdom
Cardiff & Vale University Health Board /ID# 245297
🇬🇧Cardiff, Wales, United Kingdom
UH Coventry & Warwickshire /ID# 228588
🇬🇧Coventry, United Kingdom
NHS Lothian /ID# 245293
🇬🇧Edinburgh, United Kingdom
Liverpool University Hospitals NHS Foundation Trust /ID# 245296
🇬🇧Liverpool, United Kingdom
Portsmouth Hospitals University NHS Trust /ID# 245291
🇬🇧Portsmouth, United Kingdom